Phase 2 Lung Cancer Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have been diagnosed with non-small cell lung cancer (a type of lung cancer), including all subtypes, confirmed by a tissue or cell sample
• People who have at least one brain tumour spread (metastasis) that measures between 1.0 cm and 3.5 cm across, and that a specialist radiation doctor considers safe to treat with a focused radiation technique called SRS
• People who have had a test result available showing a measure called PD-L1 (a marker on tumour cells used to guide treatment decisions)
• People whose general health and ability to carry out daily activities meets a specific level on a medical rating scale (confirm with trial site)
• People aged 18 years or older
• People whose life expectancy is greater than 3 months
• People who are able to give written agreement to take part, or who have a legally authorised representative who can do so on their behalf
• People who are willing to follow all study requirements throughout the trial
• People whose blood cell counts, kidney function, liver function, and blood clotting are within acceptable ranges — confirmed through blood tests taken without recent blood transfusions or growth factor treatments (confirm with trial site for specific values)
• People whose side effects from any previous cancer treatment or surgery have cleared up to near-normal or mild levels before joining, with some exceptions allowed for nerve pain, thyroid problems requiring medication, and hair loss
• People taking the steroid dexamethasone, as long as the dose has been reduced to 4 mg or less once daily for at least one week before joining the trial
• Women of childbearing potential who agree to use a highly effective form of contraception from the start of screening until 90 days after the last dose of the study drug
• Men who have not had a sterilisation procedure and who have a female partner who could become pregnant, or who have a pregnant or breastfeeding partner, and who agree to use a condom for the duration of treatment and until 90 days after the last dose of the study drug, with the female partner also agreeing to use a highly effective form of contraception during this time

Who may not be able to join:

• People whose lung cancer has been confirmed as small cell lung cancer (a different type of lung cancer)
• People whose brain metastasis has already been treated with the same focused radiation technique (SRS) that would be used in this trial — other types of previous brain radiation may be allowed (confirm with trial site)
• People who are unable to have a brain MRI scan with contrast dye
• People who have a brain metastasis located in the brainstem that is 1.0 cm or larger in diameter
• People who have cancer spreading through the fluid surrounding the brain and spinal cord (leptomeningeal disease)
• People who have previously received immunotherapy treatment, unless the cancer was non-metastatic, was treated with immunotherapy for the purpose of cure, and the cancer did not come back until at least 12 months after that immunotherapy ended
• People who have had another cancer diagnosis (other than non-small cell lung cancer) within the 3 years before joining — some exceptions may apply for certain cancers that were fully treated locally or are not currently requiring systemic treatment (confirm with trial site)
• People who have had major surgery or serious injury within 4 weeks before joining, or who have major surgery planned within 4 weeks of starting the study drug, or who have had a minor procedure within 3 days of joining (some exceptions apply — confirm with trial site)
• People who have a history of significant bleeding problems or a tendency to bleed, including coughing up blood, nosebleeds, or unstable use of blood thinning or anti-clotting medications within 4 weeks before joining
• People with high blood pressure that remains poorly controlled (consistently 150 mmHg or higher on the top number, or 100 mmHg or higher on the bottom number) even after taking blood pressure medication
• People with an active autoimmune disease or lung disease that has required certain medications (such as immune-suppressing drugs or higher-dose steroids) within the past 2 years — some treatments such as hormone replacement or inhaled medications may be allowed (confirm with trial site)
• People with a history of serious heart conditions, severe blood vessel disease, serious stomach or bowel problems, blood clots in arteries, severe vein clots, stroke, or mini-stroke within the timeframes specified (confirm with trial site for exact timeframes)
• People whose scans show that the tumour is growing into or around major blood vessels or vital structures in the chest, or where there is a high risk of serious bleeding based on scan findings
• People with a previous history of bleeding in the brain — cases where a brain metastasis appears to have some bleeding within it will be reviewed individually by the lead doctors
• People who have received a live vaccine within 4 weeks before joining the trial, or who plan to receive one during the study
• People who have had a serious infection within 4 weeks before joining, or who are currently on treatment for an active infection (with some exceptions for hepatitis B or C antiviral treatment)
• People who already have moderate to severe nerve damage (neuropathy) in their hands or feet before joining
• People with uncontrolled fluid build-up around the lungs, heart, or abdomen that is causing symptoms — people managing this with a drainage tube may be allowed
• People with a history of lung inflammation (not caused by infection) that required treatment with higher-dose steroids, or who currently have scarring lung disease
• People with a current or past history of inflammatory bowel disease, such as Crohn's disease or ulcerative colitis
• People with HIV whose virus is not currently under control with treatment — people with HIV on effective treatment and with undetectable levels of virus within the past 6 months may be considered
• People who have had an organ transplant or bone marrow/stem cell transplant from another person
• People with active hepatitis B infection whose virus levels have not been stable or decreasing on appropriate antiviral treatment for at least one month before joining
• People with a history of hepatitis C who have not been successfully treated and cleared of the virus, or who are currently on hepatitis C treatment but still have detectable virus levels
• People with a known allergy to any ingredient in the study drug, or a history of a severe allergic reaction to similar types of medicines (monoclonal antibodies)
• People with any medical, surgical, or mental health condition that, in the treating doctor's opinion, could interfere with the study results or the person's ability to participate safely for the full duration of the trial
• People who are currently breastfeeding or who plan to breastfeed during the study

Important: Always verify eligibility with the trial site directly before applying.